Indomethacin

Product manufactured by Avpak

Application Nr Approved Date Route Status External Links
ANDA091240 2011-04-12 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Carefully Consider The Potential Benefits And Risks Of Indomethacin Capsules And Other Treatment Options Before Deciding To Use Indomethacin. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Indomethacin Capsule, Usp Has Been Found Effective In Active Stages Of The Following: Moderate To Severe Rheumatoid Arthritis Including Acute Flares Of Chronic Disease. Moderate To Severe Ankylosing Spondylitis. Moderate To Severe Osteoarthritis. Acute Painful Shoulder (bursitis And/or Tendinitis). Acute Gouty Arthritis.

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Indomethacin INDOMETHACIN ZINC601283

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